Amlodipine Plus Botulinum Toxin for Focal Dystonia

Completed · Phase 2

Conditions studied: Focal Dystonia

In brief

Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. Study Population: 20 patients with cervical dystonia Design: Double-bind, placebo-controlled clinical trail. Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.

Key facts

Study ID

NCT00015457

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

16

Starts

2001-04-01

Last updated by the study team

2013-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection
• Present or past cardiac disease, hypertension, arrhythmia or congestive heart failure
• Anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections
• Use of concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids
• Allergy to amlodipine or related compounds
• Pregnany/ nursing
• Age less than 18 years of age
• Abnormal EKG
• Abnormal coagulation profile or liver function tests
• Use of anticoagulants

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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